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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. The lids were then gently held together for about one second. the other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
CAS no.: 108-42-9
purity: 99.5%
molecular weight. 127.6 g/mol
appearance: weak yellow liquid
stability: warranted for the test period

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 male rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

The test substance was slight to moderately irritating to the eye. According Directive 67/548 EEC a classification is not required - however according GHS a classification a Eye Irrit.2; H319 is justified based on a cornea score > 1and a conjunctiva score > 2.

Applicant's summary and conclusion

Executive summary:

100 µl test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits. The lids were then gently held together for about one second. the other eye remained untreated and served as control. The treated eye was washed out with physiological NaCl solution 24 hours after instillation of the test compound.

The test substance was slight to moderately irritating to the eye. According Directive 67/548 EEC a classification is not required - however according GHS a classification as Eye Irrit.2; H319 is justified, based on a cornea score>1and a conjunctiva score>2.